U.S. patent number 9,060,799 [Application Number 14/271,890] was granted by the patent office on 2015-06-23 for retraction of the left atrial appendage.
The grantee listed for this patent is Albert N. Santilli. Invention is credited to Albert N. Santilli.
United States Patent |
9,060,799 |
Santilli |
June 23, 2015 |
Retraction of the left atrial appendage
Abstract
A clamp is provided for attachment to the left atrial appendage
(LAA). The clamp can be locked in a closed position so as to remain
in place on the LAA. After being attached to the LAA, the clamp can
be moved to a desired position such that the LAA can be retracted
to a desired extent. The clamp can be held in any desired position,
preferably by being connected to a thoracic retractor that is being
used to retract the patient's sternum or ribs. A movable member is
connected between the clamp and a stationary portion of the
retractor. By locking the movable member in a fixed position
relative to the stationary portion, the clamp can be maintained in
a desired position and the LAA can be retracted as desired.
Inventors: |
Santilli; Albert N. (Pepper
Pike, OH) |
Applicant: |
Name |
City |
State |
Country |
Type |
Santilli; Albert N. |
Pepper Pike |
OH |
US |
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Family
ID: |
38322955 |
Appl.
No.: |
14/271,890 |
Filed: |
May 7, 2014 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20140243606 A1 |
Aug 28, 2014 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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11567538 |
Dec 6, 2006 |
8740787 |
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60762993 |
Jan 27, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/28 (20130101); A61B 17/0206 (20130101); A61B
17/2833 (20130101); A61B 17/282 (20130101); A61B
2017/0237 (20130101); A61B 2017/2808 (20130101) |
Current International
Class: |
A61B
17/28 (20060101); A61B 17/02 (20060101) |
Field of
Search: |
;600/201-246
;606/207,227 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Beccia; Christopher
Attorney, Agent or Firm: Porter, Jr.; Wayne D.
Parent Case Text
REFERENCE TO RELATED APPLICATIONS
The present application is a division of U.S. patent application
Ser. No. 11/567,538, filed Dec. 6, 2006 by Albert N. Santilli,
entitled Retraction of the Left Atrial Appendage ("the '538
application"), which incorporated by reference and claimed priority
from U.S. Provisional Patent Application Ser. No. 60/762,993, filed
Jan. 27, 2006 by Albert N. Santilli, entitled Retraction of the
Left Atrial Appendage ("the '993 application"). Applicant
incorporates by reference and claims priority from the '538
Application and the '993 Application. Reference also is made to
U.S. patent application Ser. No. 11/315,799, filed Dec. 22, 2005 by
Albert N. Santilli, et al., entitled Exclusion of the Left Atrial
Appendage (the "Left Atrial Appendage Exclusion patent"), the
disclosure of which is incorporated herein by reference.
Claims
What is claimed is:
1. A method of retracting the left atrial appendage (LAA) of a
heart during the course of a cardiovascular surgical procedure,
comprising the steps of: providing a clamp, the clamp having jaws
that are movable between a first, closed position and a second,
open position, the jaws in the closed position configured for
clamping the LAA between them and the jaws in the open position
being released from the LAA; attaching the clamp to the LAA by
moving the jaws to the closed position; moving the clamp to a
selected position where the LAA is stretched to a desired extent;
and holding the clamp in the selected position.
2. The method of claim 1, wherein the step of holding the clamp in
the selected position is accomplished by: providing a thoracic
retractor; engaging a patient's sternum or ribs with the retractor
to retract the sternum or ribs, the retractor, while retracting the
sternum or ribs, having a stationary portion that remains
stationary during the surgical procedure; providing a movable
member; connecting the movable member to the clamp; connecting the
movable member to the stationary portion such that the movable
member and the clamp are movable relative to the stationary
portion; moving the movable member and the clamp to the selected
position; and maintaining the movable member and the clamp in the
selected position.
3. The method of claim 1, further comprising the steps of:
providing a rod that projects outwardly from the clamp; and the
steps of moving the clamp to a selected position where the LAA is
stretched to a desired extent and holding the clamp in the selected
position includes the step of engaging the rod.
4. The method of claim 1, wherein the clamp is of the Pennington
tissue forceps type.
5. The method of claim 4, wherein the LAA-engaging portions of the
jaws are knurled or otherwise textured.
6. The method of claim 3, wherein the steps of engaging the rod and
retracting the clamp to a desired retracted position relative to
the heart while the jaws are in the closed position and are clamped
to the LAA and the step of holding the clamp in the desired
retracted position while the jaws are in the closed position and
are clamped to the LAA includes the step of providing: a thoracic
retractor, the retractor being engageable with a patient's sternum
or ribs to retract the sternum or ribs, the retractor, while
retracting the sternum or ribs, having a stationary portion that
remains stationary during the surgical procedure; and a movable
member, the movable member being connected to the rod, the movable
member also being connected to the stationary portion and movable
relative thereto, the movable member capable of being locked in a
desired position relative to the stationary portion.
7. The method of claim 6, wherein: the rod is L-shaped; and the
movable member includes a first universal clamp that connects the
L-shaped rod and the thoracic retractor.
8. The method of claim 7, further comprising the steps of
providing: a second rod that is connected to the thoracic retractor
and maintained in a fixed position relative thereto; a second
universal clamp; and a third rod, wherein the first universal clamp
is connected between the L-shaped rod and the third rod, and the
second universal clamp is connected between the second rod and the
third rod.
9. The device of claim 7, further comprising the steps of
providing: a second rod; a second clamp to which the second rod is
connected, the second clamp being connected to the thoracic
retractor such that the second rod can be moved relative to the
thoracic retractor and then locked in a fixed position relative to
the thoracic retractor; and the first universal clamp being
connected to the second rod.
10. The device of claim 6, wherein the movable member comprises an
adjustable gooseneck connector having first and second ends, the
clamp being connected to the first end of the gooseneck connector
and the second end of the gooseneck connector being connected to
the thoracic retractor.
11. A method of retracting the left atrial appendage (LAA) of a
heart during the course of a cardiovascular surgical procedure,
comprising the steps of: providing a clamp of the Pennington tissue
forceps type, the clamp having jaws that are movable between a
first, closed position and a second, open position, the jaws in the
closed position configured for clamping the LAA between them and
the jaws in the open position being released from the LAA, the
LAA-engaging portions of the jaws being knurled or otherwise
textured; attaching the clamp to the LAA by moving the jaws to the
closed position; moving the clamp to a selected position where the
LAA is stretched to a desired extent; holding the clamp in the
selected position by providing a thoracic retractor; engaging a
patient's sternum or ribs with the retractor to retract the sternum
or ribs, the retractor, while retracting the sternum or ribs,
having a stationary portion that remains stationary during the
surgical procedure; providing a movable member; connecting the
movable member to the clamp; connecting the movable member to the
stationary portion such that the movable member and the clamp are
movable relative to the stationary portion; moving the movable
member and the clamp to the selected position; and maintaining the
movable member and the clamp in the selected position.
12. The method of claim 11, further comprising the steps of:
providing a first rod that projects outwardly from the clamp; and
the steps of moving the clamp to a selected position where the LAA
is stretched to a desired extent and holding the clamp in the
selected position includes the step of engaging the first rod with
the movable member.
13. The method of claim 12, wherein: the first rod is L-shaped; and
the movable member includes a first universal clamp that connects
the first rod and the thoracic retractor.
14. The method of claim 13, further comprising the steps of
providing: a second rod that is connected to the thoracic retractor
and maintained in a fixed position relative thereto; a second
universal clamp; and a third rod, wherein the first universal clamp
is connected between the first rod and the third rod, and the
second universal clamp is connected between the second rod and the
third rod.
15. The device of claim 13, further comprising the steps of
providing: a second rod; a second clamp to which the second rod is
connected, the second clamp being connected to the thoracic
retractor such that the second rod can be moved relative to the
thoracic retractor and then locked in a fixed position relative to
the thoracic retractor; and the first universal clamp being
connected to the second rod.
16. The device of claim 12, wherein the movable member comprises an
adjustable gooseneck connector having first and second ends, the
first rod being connected to the first end of the gooseneck
connector and the second end of the gooseneck connector being
connected to the thoracic retractor.
Description
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates to cardiovascular surgery and, more
particularly, to techniques for retraction and subsequent exclusion
of the left atrial appendage.
2. Description of the Prior Art
Embolic stroke is a major cause of disability and death. The most
common cause of embolic stroke emanating from the heart is thrombus
formation due to atrial fibrillation. Atrial fibrillation is an
arrhythmia of the heart that results in a rapid and chaotic
heartbeat that produces lower cardiac output and irregular and
turbulent blood flow in the vascular system. There are over five
million people worldwide with atrial fibrillation, with about four
hundred thousand new cases reported each year. Atrial fibrillation
is associated with a 500 percent greater risk of stroke due to the
condition. A patient with atrial fibrillation typically has a
significantly decreased quality of life due, in large part, to the
fear of a stroke, and the pharmaceutical regimen necessary to
reduce that risk.
For patients who have atrial fibrillation and develop atrial
thrombus therefrom, the clot normally occurs in the left atrial
appendage (LAA) of the heart. The LAA is a cavity that is connected
to the lateral wall of the left atrium between the mitral valve and
the root of the left pulmonary vein. The LAA normally contracts
with the rest of the left atrium during a normal heart cycle, thus
keeping blood from becoming stagnant therein. However, the LAA,
like the rest of the left atrium, does not contract in patients
experiencing atrial fibrillation due to the discoordinate
electrical signals associated with atrial fibrillation. As a
result, thrombus formation is predisposed to form in the stagnant
blood within the LAA. Of the patients with atrial thrombus, a large
majority have the atrial thrombus located within the LAA. The
foregoing suggests that the elimination or containment of the
thrombus formed within the LAA of patients with atrial fibrillation
would significantly reduce the incidence of stroke in those
patients.
Pharmacological therapies for stroke prevention such as oral or
systemic administration of blood thinning agents, such as warfarin,
coumadin or the like have been inadequate due to serious side
effects of the medications (e.g. an increased risk of bleeding) and
lack of patient compliance in taking the medication.
As an alternative to drug therapy, invasive surgical procedures for
closing or altering the LAA have been proposed. For example, U.S.
Pat. No. 6,652,555 discloses a barrier device in the form of a
membrane for covering the ostium of the LAA to prevent blood clots
in the LAA from escaping and entering the blood stream. Published
U.S. Patent Application No. 2005/0004652 discloses an occlusion
device for inhibiting compression of the LAA in which tissue
in-growth onto the occlusion member is provided. Both of these
devices are extremely invasive in that the LAA must be opened
(usually during the course of open heart surgery) and a foreign
device implanted therein. The implanting process itself is time
consuming to perform and increases the risk of hemorrhage and
infection.
Another approach has been to attempt to close the LAA by means of
an externally applied device or instrument. For example, U.S. Pat.
No. 6,488,689 discloses that closure of the LAA can be accomplished
by a loop of material, such as a suture, wire, tape, mesh, or the
like, which can be applied over the LAA and cinched in place to
close the LAA. The '689 patent also discloses that closure can be
accomplished by stapling, clipping, fusing, gluing, clamping,
riveting, or the like. Published U.S. Patent Application Nos.
2005/0149068 and 2005/0149069 disclose several types of clamps that
can be fitted about the LAA externally and the compressed against
the LAA.
The Left Atrial Appendage Exclusion patent discloses an externally
applied exclusion device for the LAA that is easy to apply. The
device in question will apply the proper amount of compressive
force to exclude the LAA while minimizing or avoiding any stress
concentrations that would lead to undesired tissue necrosis.
Moreover, the device will avoid punctures that would lead to
difficult-to-control bleeding.
Although externally applied devices and techniques, particularly
those disclosed in the Left Atrial Appendage Exclusion patent,
offer a relatively simple and effective approach to the problem of
excluding the LAA, a particular problem has not been addressed.
This problem relates to properly grasping and positioning the LAA
so that a suitable exclusion device can be applied thereto.
Typically, a surgical assistant manually grasps the LAA and pulls
outwardly. The LAA will be slightly stretched so that the exclusion
device can be applied by the surgeon. A significant problem with
this approach is that the LAA usually is very slippery due to the
tactile qualities of its surface and due to the presence of fluids
such as blood. This makes it quite difficult for the surgical
assistant to grasp the LAA and maintain a proper grip. In addition,
because the operating theater is quite small, the presence of the
surgical assistant's hand means that the surgeon's access to the
LAA is impeded. Impeded access to the LAA makes it more difficult
and time-consuming for the surgeon to properly apply the exclusion
device to the LAA.
Desirably, a technique would be available that would permit the LAA
to be grasped readily. Preferably, any such technique would enable
the LAA to be grasped firmly and retracted to any position desired
by the surgeon while providing minimal interference with the
surgeon's access to the LAA.
SUMMARY OF THE INVENTION
In response to the foregoing concerns, the present invention
provides a new and improved technique to grasp and retract the LAA
and thereafter maintain it in a desired position. The invention
comprises a clamp that can be attached to the end of the LAA and
locked in a closed position so as to remain in place on the LAA.
Preferably the facing portions of the clamp are knurled or
otherwise textured in order to enable the clamp to grasp the LAA
more securely. The clamp can be held in a desired position in a
number of ways, preferably by being adjustably attached to a
thoracic retractor that is being used to retract the patient's
sternum or ribs.
A typical retractor usable with the invention has opposed arms that
are connected by a toothed crossbar. The arms each have a grip that
engages a portion of the patient's sternum or ribs. In one
embodiment of the invention, the clamp includes a rod that projects
outwardly thereof. A rod that normally is attached to, or included
as part of, the retractor can be connected to the rod projecting
from the clamp by means of one or more universal clamps. In another
embodiment, a removable vertically oriented rod can be connected to
the retractor. The rod can be connected to the rod projecting from
the clamp by means of a universal connector. In yet another
embodiment, an adjustable "gooseneck" is connected at one end to a
housing that can be attached to the retractor. The gooseneck is
attached at its other end directly to the clamp.
In each of the referenced embodiments, the clamp can be attached to
the LAA and then retracted to a desired position where it can be
locked in place and held there without human assistance. Not only
does the clamp enable the LAA to be grasped securely and positioned
as desired, but it also provides the surgeon enough room to work on
the LAA without interference.
The foregoing and other features and advantages of the invention
are more fully described in the accompanying specification and
claims and illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a clamp and retractor according to
the invention showing the clamp in an extended position where it is
grasping a patient's LAA;
FIG. 2 is a view similar to FIG. 1 showing the clamp and the LAA in
retracted positions;
FIG. 3 is a perspective view of the clamp of FIG. 1 showing a rod
connected to, and projecting from, the clamp;
FIG. 4 is a perspective view of another embodiment of the invention
showing the clamp of FIG. 1 attached to a retractor by a removable,
vertically extending rod; and
FIG. 5 is a perspective view of another embodiment of the invention
showing the clamp of FIG. 1 connected to a retractor by a
removable, adjustable gooseneck.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring initially to FIG. 3, a clamp according to the invention
is indicated by the reference numeral 10. The clamp 10 includes a
pair of arms 12, each of which has an enlarged, flat-sided
triangle-shaped jaw 14. The jaws 14 are knurled or otherwise
textured as indicated by the reference numeral 16 on the sides that
face each other. Handles 18 project from the arms 12. A finger loop
20 is disposed at the end of each of the handles 18. Tabs 22 with
interlocking teeth 24 extend toward each other from a location
adjacent the loops 24. A pivot pin (not shown) joins the arms 12
and the handles 18.
The clamp 10 includes an L-shaped rod 26. The rod 26 has legs 28,
30. Leg 28 is shorter than the leg 30 and is connected at one end
to the side of one of the arms 12. The leg 30 extends away from the
jaws 18 toward the loops 20 along a line intermediate the handles
18.
Preferably, the clamp 10 is a so-called Pennington tissue forceps
that is commercially available in a variety of sizes and shapes. As
illustrated, the arms 12 are generally parallel with each other
when the clamp 10 is closed; the handles 18 diverge from each other
in this position. A typical dimension for the jaws 14 is 14.7 cm in
length.
Referring now to FIGS. 1 and 2, the clamp 10 is attached to a
thoracic retractor 40. The retractor 40 is commercially available
from Kapp Surgical Instrument, Inc., 4919 Warrensville Center Road,
Cleveland, OH 44128 under the trademark COSGROVE. Reference is made
to U.S. Re. 34,150, issued Dec. 29, 1992, to A. E. Santilli and D.
M. Cosgrove III, the disclosure of which is incorporated herein by
reference, for a full description of the retractor 40. Reference
also is made to U.S. Pat. No. 6,099,468, issued Aug. 8, 2000 to
Albert N. Santilli and Amit Patel, the disclosure of which is
incorporated herein by reference, for a description of a similar
retractor that includes additional features such as suture
holders.
The retractor 40 has opposed grips 42, 44 disposed at the ends of
arms 46, 48. The arm 48 is rigidly attached to a toothed crossbar
50. The arm 46 is movable along the crossbar 50 by means of a
pinion 52 from which a handle 54 projects. A bar 56 is disposed
atop each of the arms 46, 48. Brackets 58, 60 are mounted to a
selected bar 56 and secured in position there by set screws 62. A
first rod 64 is connected to the upper portion of the brackets 58,
60 and is held in a position above the selected arm 46, 48 in
general alignment with the longitudinal axis of the arm 46, 48. A
second, generally Z-shaped rod 65 is connected to the bracket 58.
The rod 65 has an elongate portion 66 that is aligned generally
parallel with the crossbar 50. The rod 65 is connected to the
bracket 58 by fitting a slotted end of the rod 65 about a shoulder
bolt 67 that can be tightened in place on the bracket 58.
A first universal clamp 68 is connected to the elongate portion 66
of the rod 65. A third, straight rod 70 is connected to the second
rod 65 by means of the universal clamp 68. A second universal clamp
72, substantially identical to the first universal clamp 68, is
mounted to the third rod 70. The leg 30 of the rod 26 also is
connected to the universal clamp 72.
As can be seen from an examination of FIGS. 1 and 2, the universal
clamps 68, 72 can be adjusted such that the jaws 14 are moved to a
position to grasp the end of the LAA (FIG. 1). After the teeth 24
of the interlocking tabs 22 have been engaged to retain the jaws 14
firmly in place on the LAA, the clamp 10 can be moved to the right
and/or upwardly (FIG. 2) in order to retract and slightly stretch
the LAA. The surgeon then will have access to the LAA to apply an
exclusion device without interference from a surgical assistant. As
will be appreciated, the clamp 10 can be attached to the retractor
40 and adjusted to any desired position very quickly. Also, when
work on the LAA has been completed, the clamp 10 and its supporting
rods and clamps can be removed from the retractor in a matter of
seconds.
Referring now to FIG. 4, an alternative embodiment of the invention
is indicated by the reference numeral 80. The embodiment 80 uses
much of the structure of the previously described clamp 10 and
retractor 40, and like reference numerals will be used where
appropriate. The embodiment 80 has a block 82 that is adapted to
fit over the toothed crossbar 50 and to be secured in place there
by a set screw 84. A rod 86 extends vertically upwardly from the
block 82. The universal clamp 68 is attached to the rod 86. The leg
30 of the rod 26 is connected to the rod 86 by means of the
universal clamp 68.
Operation of the embodiment 80 is similar to operation of the
first-described embodiment, except that the clamp 68 can only be
moved vertically along the rod 86. The rod 86, however, can be
moved horizontally along the crossbar 50 and secured in any desired
position.
Referring now to FIG. 5, an alternative embodiment of the invention
is indicated by the reference numeral 90. The embodiment 90 uses
much of the structure of the previously described clamp 10 and
retractor 40, and like reference numerals will be used where
appropriate. The embodiment 90 uses a flexible "gooseneck" 92 to
hold the clamp 10 in a desired position. Reference is made to U.S.
Pat. No. 6,361,492, issued Mar. 26, 2002 to Albert N. Santilli, the
disclosure of which is incorporated herein by reference, for a full
disclosure of the gooseneck 92. As more fully described in the '492
patent, a housing 94 is adapted to fit over the toothed crossbar 50
and to be secured in place there by a set screw 96. A plurality of
small, tubular members 98 disposed in end-to-end relationship and
an internal cable (not shown) extend from the housing 94. The
distal end of the internal cable is connected to a fitting 100 that
in turn is directly connected to the side of the clamp 10, as by
soldering (the rod 26 is not used in this embodiment). A handle 102
carried by the housing 94 is used to loosen or tighten the internal
cable. A nut 104 and a locknut 106 are used to pre-tension the
internal cable.
As will be apparent from an examination of FIG. 5 and a review of
the '492 patent, the housing 94 can be positioned on the crossbar
50 where desired. Upon loosening the handle 102, the fitting 100
with the clamp 10 attached can be moved to any desired position.
After the desired position has been attained, the handle 102 can be
moved so as to tighten the internal cable and lock the members 98
in the desired position. As with the other embodiments of the
invention, the third embodiment 90 can be removed from the
retractor 40 in a matter of seconds.
The block 82 and the housing 94 have been disclosed as being
attached to the crossbar 50. If desired, these members could be
attached to one of the arms 46, 48, presumably the fixed arm 46
because that arm typically would be positioned on the left side of
the patient's chest. Also, the clamp 10 has been disclosed as a
Pennington tissue forceps, but different types of clamps such as
commercially available "Bulldog" clamps can be used as part of the
invention. In addition, the second rod 65 has been disclosed as
being connected to the bracket 58. It also is possible to connect
the second rod 65 to the other bracket 60.
Although the present invention has been described in detail, it
will be apparent to those skilled in the art that various changes
and modifications can be made without departing from the true
spirit and scope of the invention as hereinafter claimed. It is
intended that all such changes and modifications be encompassed
within the scope of the present claims.
* * * * *